ANCILLARY SURGICAL INSTRUMENT Instructions for Use

ANCILLARY SURGICAL INSTRUMENT
Instructions for Use
DESCRIPTION
ArthroCare Ancillary Surgical Instruments are nonpowered hand-held devices designed for use during surgical procedures
to manipulate tissue and for use with other devices during orthopedic surgeries. Ancillary Surgical Instruments can be
reused after appropriate cleaning and sterilization.
WARNINGS AND PRECAUTIONS
Warnings
• Endoscopic surgical procedures requiring specialized knowledge (e.g. knot tying, suture management) are important
considerations for successful utilization of this equipment.
• As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this
instrument. Excessive force can result in failure.
• Always actuate the instrument prior to clinical use to verify the device is functioning properly.
• If the instrument does not function properly and smoothly, immediately discontinue use and contact and ArthroCare
Customer Service Representative.
Precautions
A surgeon should not begin clinical use of the instrument without reviewing the instructions for use and practicing the
procedure in a skills laboratory.
MATERIALS
Surgical grade stainless steel and (where applicable) medical grade plastic and/or aluminum
PREPARATION FOR USE
The Ancillary Surgical Instrument is provided non-sterile and must be cleaned and sterilized prior to every use.
CLEANING
Immediately after each procedure, and before sterilization, the instrument should be manually cleaned with a standard
enzymatic detergent (ENZOL or equivalent prepared per manufacturer’s instructions) and lukewarm water. Scrub with a soft
brush to remove any visible debris. Instrument immersion is permitted. After cleaning, rinse with water and inspect. Repeat
cleaning procedure if any visible debris remains. As an alternative to manual cleaning, devices may be machine cleaned
using a suitable laboratory washer using the following cycle: (1) Prewash: 2 minutes minimum, cold water; (2) Enzyme Wash
(Enzol or equivalent according to manufacturer’s instructions): 2 minutes minimum, hot water; Wash Cycle (Renu-Klenz or
equivalent according to manufacturer’s instructions): 2 minutes minimum in hot water that is at least 66°C; Rinse: 1 minute
minimum in hot water that is at least 66°C; Dry: 7 minutes minimum at a temperature of 115°C minimum.
STERILIZATION
The instrument may be steam autoclaved. The operator should follow the sterilizer manufacturer’s instructions for steam
sterilization cycle parameters. It is recommended the instrument be steam autoclaved using the following sterilization
times and temperatures:
Pre-vacuum Sterilization Cycle (2.5 psia pre-exposure evacuation)
Exposure Temperature: A minimum of 132º C (270º F) to a maximum of 134°C (274°F)
Exposure Time: A minimum of 4 minutes to a maximum of 10 Minutes
REUSE LIFE
The devices have been qualified for up to 50 cleaning and sterilization cycles. However, any visible deterioration such as
corrosion or damage resulting from use or handling is cause for retirement of the device from further use.
CUSTOMER SERVICE
Warranty Information

The product is guaranteed for materials, function and workmanship for patient use. ArthroCare shall not be liable,
expressly or implied for:
Any damages which might arise or be caused, whether by the customer or by any of the users of the product, as a result
of:
a) Misuse, mishandling, and/or improper operation,
b) Repairs or modifications performed other than by ArthroCare or a ArthroCare authorized repair facility,
c) Use in any manner or medical procedure other than those for which it is designed; and
Any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the
product.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUATORY,
INCLUDING BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A
PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON ARTHROCARE’S PART.
Product Complaints
All questions or concerns related to quality, reliability and/or durability of this product should be directed to Customer
Service or an authorized ArthroCare representative. Please contact Customer Service or an authorized ArthroCare
representative for a return authorization.
ArthroCare is registered trademark of ArthroCare Corporation. These products are covered by one or more U.S. patents
or patents pending.
Symbols Legend
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Consult instructions for use
Catalogue number
Lot number
Contents
Manufacturer
Date of Manufacture
Non sterile
Authorized representative in
the European Community
CE mark. The product meets
the essential requirements of
Medical Device Directive
(93/42/EEC).
Caution: Federal (USA) Law
restricts this device to sale
by or on the order of a
physician.
Manufacturer
ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085 USA
Phone: (800) 797-6520
www.arthrocare.com
Authorized European Representative
ArthroCare Europe AB
Skeppsbron 2
111 30 Stockholm, Sweden
Phone: +46 8 546 17200
P/N 23017 Rev. B
October 2009